Clinical Research Plan for Human Myopia Models

Robotrak Technologies

Status: Completed

Conditions: Human Myopia Model

Treatments: Other: No intervention measures

Study type: Observational

Funder types: Industry

Identifiers

NCT06185868

RYMX202201

Details and patient eligibility

About

Collect optical biological parameters, refractive index data, and other related parameters of myopia and refractive errors in children and adolescents, and establish an optical model of myopia in children and adolescents.

Full description

Experimental research purpose:Collect optical biological parameters, refractive index data, and other related parameters of myopia and refractive errors in children and adolescents, and establish an optical model of myopia in children and adolescents.

Case selection: This study requires the inclusion of children and adolescents aged between 4 and 18 years who have been diagnosed with myopia and refractive errors through medical examination of dilated pupils.

Plan: Collect eye parameters such as refractive power, whole eye aberration, corrected visual acuity, pupil diameter, axial length, anterior and posterior corneal surface curvature, and corneal thickness of all subjects under 9 non dilated stimuli.

Enrollment: 2,000 patients

Sex: All

Ages: 6 to 16 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Selection criteria:

1. Gender unlimited
2. Age 6-16 years old
3. Through medical optometry with dilated pupils, the spherical equivalent refractive index is within the range of -0.5DS~-8.0DS, and the cylindrical lens is ≤ -0.75DC

Exclusion criteria:

1. Patients with corneal diseases such as corneal ulcers, corneal opacities, and corneal leukoplakia

2. Patients with refractive media opacity, such as cataracts and vitreous hemorrhage

3. Glaucoma patients

4. Patients with nystagmus

5. Patients with strabismus and amblyopia

6. Patients with fundus diseases

7. Patients with a column mirror range greater than -0.75DC

8. Patients with binocular anisometropia ≥ 1.0D

9. Corneal contact lenses (such as corneal reshaping lenses, multifocal contact lenses, and RGP) with a history of wearing

10. Long term history of low concentration atropine and other ocular medications

11. Wearing history of functional lenses such as asymptotic multifocal, multi-point myopic defocus, peripheral defocus, etc

12. Patients participating in other eye clinical trials

13. Individuals with mental illness or cognitive impairment who are unable to cooperate

    • Researchers believe that other reasons are not suitable for clinical trial participants, such as poor physical condition on the day of the trial